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. 2024 Dec 18;10(1):97.
doi: 10.1186/s40942-024-00620-x.

Once-weekly semaglutide doubles the five-year risk of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 persons with type 2 diabetes

Jakob Grauslund #  1   2   3 , Andreas Abou Taha #  4   5 , Laleh Dehghani Molander  4 , Ryo Kawasaki  5   6 , Sören Möller  5   7 , Kurt Højlund  5   8 , Lonny Stokholm  5   7
Affiliations

Once-weekly semaglutide doubles the five-year risk of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 persons with type 2 diabetes

Jakob Grauslund et al. Int J Retina Vitreous. .

Abstract

Background: Nonarteritic anterior ischemic optic neuropathy (NAION) is an untreatable condition often causing severe and irreversible visual loss in the affected eye. As it has recently been implied that the use of semaglutide associates with NAION, the aim of the present study was to evaluate this risk prospectively in all persons with type 2 diabetes (T2D) in Denmark.

Methods: In a five-year longitudinal cohort study, we identified all persons with T2D in Denmark (n = 424,152) between 2018 and 2024. Patients were stratified according to exposure (n = 106,454) or non-exposure (n = 317,698) to once-weekly semaglutide, and incidence rates and hazard ratios (HR) of NAION were estimated in a multivariable Cox proportional hazard regression model.

Results: At baseline, median age and hemoglobin A1c were 65 years and 50 mmol/mol, and 54·5% were male. During 1,915,120 person-years of observation, 218 persons developed NAION. Semaglutide exposure was associated with a higher incidence rate (0·228 vs. 0·093 per 1000 person-years, p < 0·001) and independently predicted a higher risk of upcoming NAION (HR 2·19, 95% confidence interval 1·54 - 3·12), even when multiple other factors were taken into account. Overall, 67 persons exposed to semaglutide developed NAION with a median time from first prescription to event of 22·2 months (interquartile range 10·2-37·8 months).

Conclusions: During five years of observation of all persons with T2D in Denmark, use of once-weekly semaglutide independently more than doubled the risk of NAION. Given the irreversible nature of NAION, it is important to acknowledge this risk, and upcoming studies should aim to identify high-risk subgroups.

Keywords: Cohort study; Nonarteritic anterior ischemic optic neuropathy; Registry based; Semaglutide; Type 2 diabetes.

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Conflict of interest statement

Declarations. Ethical approval and consent to participate: The study was performed according to the tenets of the Helsinki Declaration, and permissions were obtained from the Danish Data Protective Agency (18/16231), the Danish Health Authorities (FSEID-00005826) and the Danish Clinical Registries (DIABASE-2018-12-11). According to Danish law, it is not required to obtain informed consent from patients or permission from the Danish National Committee on Health Research Ethics in order to perform registry-based studies. The study was performed in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines [22]. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Number of first-time episodes of nonarteritic anterior ischemic optic neuropathy (NAION) and persons with type 2 diabetes (T2D) redeeming at least one prescription of once-weekly semaglutide (Ozempic®) between January 1, 2010, and June 30, 2024
Fig. 2
Fig. 2
Time from redemption of first prescription of once-weekly semaglutide (Ozempic®) to first event of nonarteritic anterior ischemic optic neuropathy (NAION) in the 67 persons with type 2 diabetes patients, who were exposed to semaglutide and developed at least one event of NAION in 2018–2024. Box and whisker plot includes median time, interquartile range and range
See this image and copyright information in PMC

Comment in

References

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